A Phase 2 interventional study of Simvastatin and Placebo in Severe Asthma, sponsored by University of California, Davis. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by University of California, Davis · Phase 2, Interventional, and Treatment
This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy.
This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma.
The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.
See above.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
Browse Asthma studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Simvastatin 40 mg daily will be given for 12 weeks.
Drug: Simvastatin
A placebo capsule will be given daily for 12 weeks.
Other: Placebo
Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.
Also known as: Zocor
A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.
Th2 gene expression in nasal epithelial cells.
IL13, eotaxin-1,-2,-3, STAT6) by RT-PCR.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Exhaled nitric oxide (ENO)
ENO will be measured using our NIOX-Mino portable NO analyzer.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Acute Exacerbations
Assessed as a rate per month.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Lung function
FEV1, FVC, and FEV/FVC ratio.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Asthma symptom control score
Asthma Control Test score (5 question survey).
Time frame: Before and after 12 weeks of drug or placebo intervention.
This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Davis